DeprescribingNCT07226960
Deprescribing in Outpatient Internal Medicine Practices
A study testing medication review in people with Deprescribing, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of pharmacist-led medication reviews and deprescribing or de-escalation interventions on reducing the number of medications, falls, and hospitalizations, and improvement in quality of life in geriatric patients. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Deprescribing
- What is being tested?
- medication review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years or older
- taking 6 or more medications
Who cannot join
- patients in hospice or palliative care
- in Skilled Nursing Facility
- receiving cancer/oncology treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to evaluate the impact of pharmacist-led medication reviews and deprescribing or de-escalation interventions on reducing the number of medications, falls, and hospitalizations, and improvement in quality of life in geriatric patients.
Read the detailed description
With increasing age, key pharmacokinetic processes such as first-pass metabolism, bioavailability, drug distribution, and clearance, are affected, necessitating dose adjustments and careful medication management. Despite these risks, medication regimens in elderly patients are often left unchanged over time. Deprescribing, the intentional reduction or discontinuation of medications, has been shown to improve quality of life, reduce fall risk, minimize cognitive impairment, and decrease adverse drug interactions. In this analysis, the PharmD will perform a comprehensive medication review with the patient and collaborate with the provider and patient through shared decision making to deprescribe and/or dose reduce medication therapy where risks may outweigh benefits for the patient.
- Conditions
- Deprescribing
- Being tested
- medication review
- Keywords
- Polypharmacy, medication regimens, medication reviews, geriatric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication reviewBehavioural
Also called potential deprescribing / de-escalation
Internal medicine providers and PharmDs will identify patients for whom a medication review and potential deprescribing / de-escalation intervention may be beneficial.
| Study group | Role | What they receive |
|---|---|---|
| medication review - deprescribing / de-escalation may occur | Experimental | Internal medicine providers and PharmDs will identify patients for whom a medication review and potential deprescribing / de-escalation intervention may be beneficial, and make recommendations to adjust therapy as appropriate. Receives: Behavioral: medication review |
| historical controls | No intervention | No contact or intervention will be made with these patients, only retrospective chart review to gather data such as number of medications, hospitalizations, and falls. Patients included in the historical control arm will be matched to the intervention group based on sex, age, and number of medications as much as possible. The goal will be to include 50 patients in both the intervention and control arms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of medications
Change in number of medications
Measured: Month 3
Secondary outcomes (5)
Change in Medication Appropriateness Index scores
The Medication Appropriateness Index (MAI) score is a quantitative measure of prescribing appropriateness, where lower scores indicate more appropriate medication use, and higher scores indicate less appropriate use.
Each criterion is rated on a 3-point scale:
Appropriate (score of 0 or a low value) Each criterion is assigned a weight ranging from 1 to 3, with a maximum total score of 18 possible per drug.
A summated score can be calculated for a patient by combining the scores for all their medications. This summated score is not standardized, meaning the potential total score depends on the number of medications the patient is taking. A score of 0 for a medication indicates ideal or appropriate prescribing for that specific criterion. Higher scores are associated with potentially inappropriate medication (PIM) use, increased risk of adverse drug events (ADEs), higher rates of unscheduled ambulatory or emergency department visits, and lower health-related quality of life.
Measured: Month 3
Change in Quality of life scores
The Lübeck Medication Satisfaction Questionnaire (LMSQ) is scored by calculating the average score for each of its six subscales, which are based on three Likert-scale items each. Patients rate their agreement with each statement on a four-point scale (1=strongly disagree, 4=strongly agree), but items phrased negatively must be reverse-scored before calculating the subscale average. To get the subscale score, you sum the three items' scores and divide by three.
Measured: Month 3
Number of documented falls
Number of documented falls
Measured: Month 3
Number of documented hospitalizations
Number of documented hospitalizations
Measured: Month 3
Number of documented visits to Primary Care Physician office
Number of documented visits to Primary Care Physician office
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start12 Nov 2025
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeprescribingStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, mixed methods, investigator-initiated pilot quality improvement analysis
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Clements, PharmD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226960
- Sponsor's protocol ID
- IRB00137786
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing in Outpatient Internal Medicine Practices
- ClinicalTrials.gov ID
- NCT07226960
- Acronym / sponsor ID
- IRB00137786
- Conditions
- Deprescribing
- Keywords
- Polypharmacy, medication regimens, medication reviews, geriatric patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of pharmacist-led medication reviews and deprescribing or de-escalation interventions on reducing the number of medications, falls, and hospitalizations, and improvement in quality of life in geriatric patients.
Detailed description
With increasing age, key pharmacokinetic processes such as first-pass metabolism, bioavailability, drug distribution, and clearance, are affected, necessitating dose adjustments and careful medication management. Despite these risks, medication regimens in elderly patients are often left unchanged over time. Deprescribing, the intentional reduction or discontinuation of medications, has been shown to improve quality of life, reduce fall risk, minimize cognitive impairment, and decrease adverse drug interactions. In this analysis, the PharmD will perform a comprehensive medication review with the patient and collaborate with the provider and patient through shared decision making to deprescribe and/or dose reduce medication therapy where risks may outweigh benefits for the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, mixed methods, investigator-initiated pilot quality improvement analysis
| Arm | Type | Receives |
|---|---|---|
| medication review - deprescribing / de-escalation may occur | Experimental | Behavioral: medication reviewInternal medicine providers and PharmDs will identify patients for whom a medication review and potential deprescribing / de-escalation intervention may be beneficial, and make recommendations to adjust therapy as appropriate. |
| historical controls | No intervention | –No contact or intervention will be made with these patients, only retrospective chart review to gather data such as number of medications, hospitalizations, and falls. Patients included in the historical control arm will be matched to the intervention group based on sex, age, and number of medications as much as possible. The goal will be to include 50 patients in both the intervention and control arms. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 75 years or older
- taking 6 or more medications
Key exclusion criteria (3 listed)
- patients in hospice or palliative care
- in Skilled Nursing Facility
- receiving cancer/oncology treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medication reviewAlso: potential deprescribing / de-escalationInternal medicine providers and PharmDs will identify patients for whom a medication review and potential deprescribing / de-escalation intervention may be beneficial. | Behavioural | medication review - deprescribing / de-escalation may occur |
Primary outcome
Change in number of medications
Time frame: Month 3
Change in number of medications
5 secondary outcomes
Change in Medication Appropriateness Index scores
Time frame: Month 3
Change in Quality of life scores
Time frame: Month 3
Number of documented falls
Time frame: Month 3
Number of documented hospitalizations
Time frame: Month 3
Number of documented visits to Primary Care Physician office
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Clements, PharmD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medication review in people with Deprescribing, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of medications (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.